BRAF Mutant Metastatic Melanoma Clinical Trial
Official title:
A Phase 1/2 Trial of BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma (Novartis Study Number CBKM120ZUS21T)
This is a phase 1/2 clinical trial with the goal of determining whether the addition of the investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free survival in patients with BRAFV600E/K mutant melanoma.
The phase 1 portion of this trial is a dose escalation study; the phase 2 portion is a
single-stage, single arm prospective clinical trial. All patients will receive continuous
doses of vemurafenib twice a day and BKM120 once a day.
In the phase 1 portion of the study, there will be a 7 day lead-in period to allow for single
dose pharmacokinetic analysis of BKM120 alone. Cycle 1 (28 days) is the dose-limiting
toxicity (DLT) period. During phase 1, vemurafenib and BKM120 doses will be escalated using a
standard 3+3 dose escalation scheme with the goal of identifying the recommended phase 2
dose.
In the phase 2 portion of the study, patients will receive continuous doses of vemurafenib
and BKM120 starting on day 1 of the first cycle. In the phase 2 portion of the study,
patients will receive vemurafenib and BKM120 at the recommended phase 2 dose.
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